Risk of progression in chronic phase‐chronic myeloid leukemia patients eligible for tyrosine kinase inhibitor discontinuation: Final analysis of the TFR‐PRO study

Author:

Zambrotta Giovanni Paolo Maria12ORCID,Nicolini Franck E.3ORCID,Assouline Sarit4,Busque Lambert5,Pungolino Ester6,Abruzzese Elisabetta7,Miggiano Maria Cristina8,Elena Chiara9,Alvarez‐Larran Alberto10ORCID,Triguero Ana10,Iurlo Alessandra11ORCID,Bucelli Cristina11,Cerrano Marco12ORCID,Capodanno Isabella13ORCID,Lunghi Francesca14,le Coutre Philipp15,Galimberti Sara16ORCID,Caocci Giovanni17,Maffioli Margherita18,Stagno Fabio19,Saussele Susanne20,Piazza Rocco12ORCID,Druker Brian J.21,Fava Carmen22,Guglielmana Veronica12,Colombo Federica12,Antolini Laura1,Gambacorti‐Passerini Carlo12ORCID

Affiliation:

1. Department of Medicine and Surgery University of Milano‐Bicocca Monza Italy

2. Hematology Department Fondazione IRCCS San Gerardo dei Tintori Monza Italy

3. Hématologie clinique & INSEM U1052 Centre Léon Bérard Lyon France

4. Department of Medicine and Oncology, Jewish General Hospital McGill University Montreal Quebec Canada

5. Hematology Division, Research Center, Hôpital Maisonneuve‐Rosemont Université de Montréal Montreal Quebec Canada

6. Division of Hematology ASST Grande Ospedale Metropolitano Niguarda Milan Italy

7. Hematology, S. Eugenio Hospital, ASL Roma2 Tor Vergata University Rome Italy

8. Hematology Department San Bortolo Hospital Vicenza Italy

9. Department of Hematology Oncology, Foundation IRCCS Policlinico San Matteo University of Pavia Pavia Italy

10. Hematology Department Hospital Clínic Barcelona Spain

11. Hematology Division Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan Italy

12. Department of Hematology University‐Hospital Città della Salute e della Scienza Turin Italy

13. Hematology Unit Azienda Unità Sanitaria Locale‐IRCCS di Reggio Emilia Reggio Emilia Italy

14. Department of Onco‐Haematology ‐ Haematology and Bone Marrow Transplantation IRCCS San Raffaele Scientific Institute and Vita‐Salute Hospital Milan Italy

15. Department of Hematology, Oncology and Tumor Immunology Charité Campus Mitte, Charité‐Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt‐Universität zu Berlin Berlin Germany

16. Section of Hematology, Department of Clinical and Experimental Medicine, Azienda ospedaliera Pisana University of Pisa Pisa Italy

17. Hematology Unit Cagliari University, Businco Hospital Cagliari Italy

18. Hematology Unit ASST Sette Laghi, Ospedale di Circolo Varese Italy

19. Division of Hematology and Bone Marrow Transplantation Unit, A.O.U. "Policlinico‐Vittorio Emanuele" University of Catania Catania Italy

20. Department of Hematology and Oncology, University Hospital Mannheim Heidelberg University Mannheim Germany

21. Division of Hematology/Medical Oncology, Knight Cancer Insitute Oregon Health & Science University Portland Oregon USA

22. Department of Clinical and Biological Sciences University of Turin Torino Italy

Abstract

AbstractDisease progression to accelerated/blast phase (AP/BP) in patients with chronic phase chronic myeloid leukemia (CP‐CML) after treatment discontinuation (TD) has never been systematically reported in clinical trials. However, recent reports of several such cases has raised concern. To estimate the risk of AP/BP among TD‐eligible patients, we conducted TFR‐PRO, a cohort retro‐prospective study: 870 CP‐CML patients eligible for TD formed a discontinuation cohort (505 patients) and a reference one (365 patients). The primary objective was the time adjusted rate (TAR) of progression in relation to TD. Secondary endpoints included the TAR of molecular relapse, that is, loss of major molecular response (MMR). With a median follow up of 5.5 years and 5188.2 person‐years available, no events occurred in the TD cohort. One event of progression was registered 55 months after the end of TD, when the patient was contributing to the reference cohort. The TAR of progression was 0.019/100 person‐years (95% CI [0.003–0.138]) in the overall group; 0.0 (95% CI [0–0.163]) in the discontinuation cohort; and 0.030 (95% CI [0.004–0.215]) in the reference cohort. These differences are not statistically significant. Molecular relapses occurred in 172/505 (34.1%) patients after TD, and in 64/365 (17.5%) patients in the reference cohort, p < .0001. Similar rates were observed in TD patients in first, second or third line of treatment. CML progression in patients eligible for TD is rare and not related to TD. Fears about the risk of disease progression among patients attempting TD should be dissipated.

Funder

Department of Medicine and Surgery

Publisher

Wiley

Subject

Hematology

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